Position Paper: Are We Abandoning IQ and OQ?

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment."

It has been quite apparent to some of us in the pharmaceutical and medical-device industries that there appears to have been a directed effort over the past number of years to eliminate the concept of and need for the installation qualification (IQ) and the operational qualification (OQ). These two techniques were developed by the industry in answer to the validation requirement mandated by the US Food and Drug Administration (1). The purpose of IQ and OQ was to verify that equipment and systems were able to perform as intended.

Over the years, with the need to compress the timeline for products to be marketed and to decrease the cost associated with the build-out of a new facility or process, IQ and OQ documents have been massaged and varied in complexity and content. The IQ and OQ were also combined into a single-document format to save on paperwork as well as review and approval time. This new combination became known as the IOQ.

Industry over the years has been pushing FDA for acceptance regarding a cutback on the apparent redundancy associated with the validation process. It was argued that those validating were conducting tests that had already been performed during equipment design and installation. Quality assurance (QA) was also to blame since they were reviewing aspects of the installation and qualification that were not necessary. They were a bottleneck due to the time required for review, intrusive question and answer sessions, minuscule document oversights, and unessential general approval.

Today many companies still follow the premise of IQ and OQ, but the introduction of other terms has downsized the importance of these activities. In particular, the term commissioning was introduced into the vernacular of the industry. The purpose of commissioning was actually threefold:

Commissioning was used to capture the pre-installation Factory Acceptance Test (FAT) and installation testing that was being performed on the equipment and systems being installed.

Commissioning was viewed as taking the place of the need to qualify those systems and equipment that were not deemed critical but supportive in nature. Systems such as plant steam, vacuum, and heat transfer no longer required qualification. Commissioning allowed them to stand on their own documentation merits and any associated verification would reside in the associated commissioning documentation. New terms such as good engineering practices (GEP) would ensure that these documents were correct and usable.

The third purpose of commissioning was to bridge the gap between design and installation, which was start-up. Using the information afforded through a commissioning program would reduce the apparent redundant information gathering and testing that validation was being accused of performing.

Over the same period of time, practitioners of commissioning were including more and more of the then-understood IQ and OQ tests as part of the commissioning exercise. This practice has been altered to such an extent that the IQ and OQ have been reduced to lists indicating that prior commissioning test had been properly completed. In essence, documents (IQ and OQ) that were quite large in size in the past now are the smallest in volume. This occurred to such an extent that the IQ and OQ are now understood by some in the industry as useless documents because they had been reduced to simple lists of prior test results.

These same criticisms did not mention other qualification test requirements such as the handshaking between equipment, the testing of narrowed specificity of operational parameters associated with the particular process in mind, or the added computer-related programming or interfacing that may be necessary. It has also become acceptable to have the pretreatment aspects of critical utilities commissioned only and the final purification or critical process steps considered for qualification.

Role of QA

QA was always to be the independent reviewer and approver. QA personnel had no direct role in the design or manufacturing processes. Their reporting structure also was to be independent and separate from engineering and manufacturing. They were mandated with maintaining quality and an independent status through the regulations.

During the same timeframe, we have seen the erosion of QA in the qualification effort. Validation, which originally resided in QA, was moved to either engineering or technical services. The reason for this was that only those disciplines could properly test the equipment and systems because they had the necessary experience and education. Logically this may be justified, and many companies today have already made the move. In some cases, even the performance qualification (PQ) and process validation (PV) aspects of validation have also been removed from the QA umbrella.

With the original IQ and OQ, QA personnel reviewed and approved each document. They also reviewed the summary reports that followed regarding these activities. With the onset of commissioning, the role of QA in the overall qualification scheme came into question. Nowhere in industry guidelines was it stated that QA should review commissioning tests and commissioning-related documentation. Again, the commissioned systems and equipment would stand on the merit of their respective commissioning documentation.

Some firms introduced the term commissioning closeout reports as an effort to include QA review and involvement. Other firms included QA as a team player in the overall process, but the approval status was removed. QA was only to substantiate that critical systems were properly tested, qualified, and approved.

The concern with all of this shifting of responsibilities as well as approvals was that QA personnel were still the ones defending the company activities to the FDA and other regulatory bodies. QA is typically the group defending the company's practices and applications during an FDA inspection and not those who commissioned or reduced the involvement of QA in the overall facility-qualification effort.